POSITION SUMMARY: The Head of GxP Quality Compliance is a critical part of the global quality organization, and is both a strategic and tactical, hands-on role. Reporting to the Vice President of Global Quality, this position provides leadership to the global quality compliance team focussed on GCP and GMP compliance within R&D; GMP and GDP compliance within Commercial Supply; and GPVP compliance with Pharmacovigilance System operations. Compliance activities are delivered through the management of Global GXP internal audit programmes, generation of related quality metrics, and the review and escalation of identified quality business risks. The position is a working leader role that provides quality oversight of Client's internal compliance to Global GXP expectations and requirements set forth by national and regional Competent Authorities (FDA, EMA, MHRA etc). Lastly, the position ensures that all cGxP activities carried out within the Client Affiliate network in all territories where Client medicinal products are marketed, are compliant with GXP requirements in those territories and are in line with Client policies.
? Audits internally for GMP, but maintains external auditing for GCP and GPV functions.
? Assess the performance of the Global and Local instances of the Pharmaceutical Quality System (PQS), while identifying key risks and improvement opportunities for Client.
? Work across functional boundaries modelling the Client Guiding Principles to ensure operational alignment and driving continuous improvement.
? Liaison to the operations by identifying potential compliance gaps, and then partners with the business to help drive sustainable solutions.
- Serves as a subject matter expert on international product, process and system GXP (quality) regulations, standards, guidance documents and identified industry best practices.
Education: Bachelor of Science degree in a life science or engineering discipline. Post graduate degree is preferred. Experience:
? Advanced knowledge of global regulations relevant to a regulated product (e.g. EU cGMP, WHO, PIC/S, 21 CFR Part 4, 210, and 211.
? Proven knowledge of ICH global standards).
? Must have direct experience with the planning and execution of a global compliance plan with an international organization.
? Must have a strong background in R&D Compliance (GPV, GCLP) but also have general cGxP knowledge as well including cGMP.
? Auditing skills, appropriate qualifications in auditing an advantage
? Proficient in English. However, fluency in otherlanguages is advantageous.
? Intermediate to Advanced Knowledge of Microsoft Office (PowerPoint, Word, Excel, Outlook)
? In addition to the minimum qualifications, the employee will demonstrate:
? Strong interpersonal and communication skills and ability to communicate clearly to all levels of the business, able to deliver concise written or oral summaries to senior management.
? Executive presence for giving presentations and updates is helpful.
? Influencing skills in areas with no direct reporting authority.
? Strong planning and organisation skills.
? Auditing skills, appropriate qualifications in auditing an advantage.
Motivated by delivering high quality patient treatments in the arena of addiction.